Deviation Impact Assessment

Equipment Details

Equipment: Tablet Metal Detector (Inline)

Area: Production/Compression

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Description of Deviation: [Insert deviation description here]

Date of Deviation: [Insert date here]

Reported By: [Insert name here]

Deviation Classification

Classification: [Insert classification here]

Product/Patient Impact

Impact Assessment: [Insert product/patient impact assessment here]

Data Integrity Impact

Data Integrity Assessment: [Insert data integrity impact assessment here]

Affected Batches/Studies

Affected Batches/Studies: [List affected batches/studies here]

Investigation

Investigation Summary: [Insert investigation summary here]

Corrective and Preventive Actions (CAPA)

CAPA Plan: [Insert CAPA plan here]

Re-test/Requalification Decision

Decision: [Insert re-test/requalification decision here]

Quality Assurance Disposition

Disposition: [Insert QA disposition here]